US ~ Garnet Valley, PA
Our growing and successful business comprises of over 900 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
- Develop stable and bioavailable pharmaceutical dosage forms. Develop and optimize manufacturing processes and manufacture clinical supplies
- To comply and adhere to Good Manufacturing Practice (GMP) standards.
Main tasks and responsibilities will include:
- Essential duties and responsibilities include the following. Other duties may be assigned.
- Formulate oral solid dosage forms in a fast-paced contract manufacturing environment.
- Developed a wide array of formulations including immediate and modified release for Phase I – III.
- Scaled up formulation and processes from lab to pilot scale to commercial manufacturing.
- Scaled up and mfg. Registration/submission batches for ANDA and NDA products.
- Managed technical Transfer of commercial scale process for Product intended for U.S., Europe, and Japan.
- Interacted extensively with Customer (clients) to produce deliverables with aggressive project timelines.
- Authored product specifications, process validation protocols, batch records, and development reports.
- Coordinated QA, Analytical and Development activities to assure successful product delivery.
- Manufactured and packaged clinical supplies (Phase I – III) under cGMPs.
- Other activities as directed by supervisor, or as described in the QS Pharma Employee Manual.
- Train Manufacturing technician and new employees.
- Prepare and executed process validation batches and prepared report.
- Technical hands on process experience with immediate release, modified release solid oral dosage forms and high potent formulation
- Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedures.
- Remains current in profession and industry trends.
- Makes a positive contribution as demonstrated by:
- making suggestions for improvement
- providing overtime as needed
- learning new skills, procedures and processes.
- is available for other duties as required.
- is available for overtime as needed
The job may involve the following:
- Very high concentration of work
- Strict and tight deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working in a hazardous environment with high requirement to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands while performing the duties of this job, the employee is frequently required to stand, walk, use hands to finger, handle or feel, and talk or hear.
- The employee is occasionally required to sit, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl and taste or smell.
- The employee must occasionally lift and/or move up to 40 pounds.
- Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.
- Must be able to qualify for respiratory protective equipment use
- M.S. Degree in Chemical Engineering/Pharmacy/Pharmaceutical Sciences with plus 2-3 years’ experience in the pharmaceutical industry Or other related field or; B.S. degree in Chemical Engineering/Pharmacy/Pharmaceutical Sciences or other related field plus 5-6 years’ experience in the pharmaceutical industry
- Basic knowledge of physicochemical concepts and theories.
- Familiarity with the production process.
- Familiar with a variety of in-process equipment, such as disintegration, friability, particle size, etc.
- Successfully completes regulatory and job training requirements.
- Computer skills:
- Enter data into computer using software applications for data entry and word processing.
- Work and be proficient with e-mail systems
- Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
- Ability to perform under stress in cases of emergency, critical or hazardous situations.
- Ability to work with others in a team environment.
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.